Six-month follow-up of patient-rated outcomes in a randomized controlled trial of exercise training during breast cancer chemotherapy.

BACKGROUND: Few exercise trials in cancer patients have reported longer-term follow-up. Here, we report a 6-month follow-up of exercise behavior and patient-rated outcomes from an exercise trial in breast cancer patients. METHODS: Breast cancer patients initiating adjuvant chemotherapy (n = 242) were randomly assigned to usual care (n = 82), resistance exercise training (RET; n = 82), or aerobic exercise training (AET; n = 78) for the duration of their chemotherapy. At 6-month follow-up, participants were mailed a questionnaire that assessed quality of life, self-esteem, fatigue, anxiety, depression, and exercise behavior. RESULTS: Two hundred one (83.1%) participants provided 6-month follow-up data. Adjusted linear mixed-model analyses showed that, at 6-month follow-up, the RET group reported higher self-esteem [adjusted mean difference, 1.6; 95% confidence interval (95% CI), 0.1-3.2; P = 0.032] and the AET group reported lower anxiety (adjusted mean difference, -4.7; 95% CI, -0.0 to -9.3; P = 0.049) compared with the usual care group. Moreover, compared with participants reporting no regular exercise during the follow-up period, those reporting regular aerobic and resistance exercise also reported better patient-rated outcomes, including quality of life (adjusted mean difference, 9.5; 95% CI, 1.2-17.8; P = 0.025). CONCLUSIONS: Improvements in self-esteem observed with RET during breast cancer chemotherapy were maintained at 6-month follow-up whereas reductions in anxiety not observed with AET during breast cancer chemotherapy emerged at 6-month follow-up. Moreover, adopting a combined aerobic and resistance exercise program after breast cancer chemotherapy was associated with further improvements in patient-rated outcomes. Exercise training during breast cancer chemotherapy may result in some longer-term and late effects for selected patient-rated outcomes.     

Subgroup effects in a randomised trial of different types and doses of exercise during breast cancer chemotherapy

Background:

The Combined Aerobic and Resistance Exercise Trial tested different types and doses of exercise in breast cancer patients receiving chemotherapy. Here, we explore potential moderators of the exercise training responses.

Methods:

Breast cancer patients initiating chemotherapy (N=301) were randomly assigned to three times a week, supervised exercise of a standard dose of 25–30 min of aerobic exercise, a higher dose of 50–60 min of aerobic exercise, or a higher dose of 50–60 min of combined aerobic and resistance exercise. Outcomes were patient-reported symptoms and health-related fitness. Moderators were baseline demographic, exercise/fitness, and cancer variables.

Results:

Body mass index moderated the effects of the exercise interventions on bodily pain (P for interaction=0.038), endocrine symptoms (P for interaction=0.029), taxane/neuropathy symptoms (P for interaction=0.013), aerobic fitness (P for interaction=0.041), muscular strength (P for interaction=0.007), and fat mass (P for interaction=0.005). In general, healthy weight patients responded better to the higher-dose exercise interventions than overweight/obese patients. Menopausal status, age, and baseline fitness moderated the effects on patient-reported symptoms. Premenopausal, younger, and fitter patients achieved greater benefits from the higher-dose exercise interventions.

Conclusions:

Healthy weight, fitter, and premenopausal/younger breast cancer patients receiving chemotherapy are more likely to benefit from higher-dose exercise interventions.     

Polymorphisms in three base excision repair genes and breast cancer risk in Thai women

Few randomized controlled trials have examined the effects of combined aerobic and resistance training in breast cancer survivors soon after completing adjuvant therapy. Breast cancer survivors (N = 58) within 2 years of completing adjuvant therapy were randomly assigned to an immediate exercise group (IEG; n = 29) or a delayed exercise group (DEG; n = 29). The IEG completed 12 weeks of supervised aerobic and resistance exercise, three times per week. The DEG completed the program during the next 12 weeks. Participants completed patient-rated outcomes at baseline, 6, 12, 18 and 24 weeks. The primary endpoint was overall quality of life (QoL) measured by the Functional Assessment of Cancer Therapy-Breast scale. Secondary endpoints were fatigue, social physique anxiety, and physical fitness. Follow-up data was obtained on 97% of participants and exercise adherence was 61.3%. Repeated measures analyses of variance revealed a significant group by time interaction for overall QoL (P < 0.001). Specifically, QoL increased in the IEG from baseline to 12 weeks by 20.8 points compared to a decrease in the DEG of 5.3 points (mean group difference = 26.1; 95% CI = 18.3–32.7; P < 0.001). From 12 to 24 weeks, QoL increased in the DEG by 29.5 points compared to an increase of 6.5 points in the IEG (mean group difference = 23.0; 95% CI = 16.3–29.1; P < 0.001). Similar results were obtained for the secondary endpoints. Combined aerobic and resistance exercise soon after the completion of breast cancer therapy produces large and rapid improvements in health-related outcomes.     

Safety and feasibility of aerobic training on cardiopulmonary function and quality of life in postsurgical nonsmall cell lung cancer patients: a pilot study

BACKGROUND.

A feasibility study examining the effects of supervised aerobic exercise training on cardiopulmonary and quality of life (QOL) endpoints among postsurgical nonsmall cell lung cancer (NSCLC) patients was conducted.

METHODS.

Using a single‐group design, 20 patients with stage I‐IIIB NSCLC performed 3 aerobic cycle ergometry sessions per week at 60% to 100% of peak workload for 14 weeks. Peak oxygen consumption (VO_2peak) was assessed using an incremental exercise test. QOL and fatigue were assessed using the Functional Assessment of Cancer Therapy–Lung (FACT‐L) scale.

RESULTS.

Nineteen patients completed the study. Intention‐to‐treat analysis indicated that VO_2peak increased 1.1 mL/kg^?1/min^?1 (95% confidence interval [CI], ?0.3‐2.5; P = .109) and peak workload increased 9 W (95% CI, 3‐14; P = .003), whereas FACT‐L increased 10 points (95% CI, ?1‐22; P = .071) and fatigue decreased 7 points (95% CI; ?1 to ?17; P = .029) from baseline to postintervention. Per protocol analyses indicated greater improvements in cardiopulmonary and QOL endpoints among patients not receiving adjuvant chemotherapy.

CONCLUSIONS.

This pilot study provided proof of principle that supervised aerobic training is safe and feasible for postsurgical NSCLC patients. Aerobic exercise training is also associated with significant improvements in QOL and select cardiopulmonary endpoints, particularly among patients not receiving chemotherapy. Larger randomized trials are warranted. Cancer 2008. © 2008 American Cancer Society.     

International Collaborative Ovarian Neoplasm trial 1: a randomized trial of adjuvant chemotherapy in women with early-stage ovarian cancer

BACKGROUND: The question of whether platinum-based adjuvant chemotherapy can improve outcomes in patients with early-stage epithelial ovarian cancer is an important one. We carried out a multicenter, open randomized trial to determine whether adjuvant chemotherapy would improve overall survival and prolong recurrence-free survival in women with early-stage epithelial ovarian cancer. METHODS: Between August 1991 and January 2000, 477 patients in 84 centers in five countries were randomly assigned to receive either adjuvant chemotherapy immediately following surgery (n = 241) or no adjuvant chemotherapy until clinically indicated (n = 236). Kaplan-Meier curves of overall survival and recurrence-free survival were compared using the Mantel-Cox version of the log-rank test. All statistical tests were two-sided. RESULTS: Women who received adjuvant chemotherapy had better overall survival than women who did not (hazard ratio [HR] of 0.66, 95% confidence interval [CI] = 0.45 to 0.97; P =.03). These results translate into 5-year survival figures of 70% for women who did not receive adjuvant chemotherapy and 79% for women who did receive adjuvant chemotherapy, a difference of 9% (95% CI = 1% to 15%). Adjuvant chemotherapy also improved recurrence-free survival (HR = 0.65; 95% CI = 0.46 to 0.91; P =.01). These results translate into 5-year recurrence-free survival figures of 62% for women who did not receive adjuvant chemotherapy and 73% for women who did receive adjuvant chemotherapy, a difference of 11% (95% CI = 3% to 18%). CONCLUSION: These results suggest that platinum-based adjuvant chemotherapy improves survival and delays recurrence in patients with early-stage ovarian cancer.     

Patterns of breast carcinoma treatment in older women: patient preference and clinical and physical influences

BACKGROUND: Older women have high rates of breast carcinoma, and there are substantial variations in the patterns of care for this population group. METHODS: The authors studied 718 breast carcinoma patients age 67 years and older who were diagnosed with localized disease between 1995 and 1997 from 29 hospitals in 5 regions. Data were collected from patients, charts, and surgeons. Logistic regression analysis was used to evaluate determinants of treatment. RESULTS: Women who were concerned about body image were 1.8 times more likely (95% confidence interval [95% CI], 1.1-2.8) to receive breast conservation surgery and radiotherapy than women without this preference, controlling for other factors. In contrast, women who preferred receiving no therapy beyond surgery were 3.9 times more likely (95% CI, 2.9-6.1) to undergo mastectomy than other women, after considering other factors. Radiotherapy was omitted after breast conservation 3.4 times more often (95% CI, 2.0-5.6) among women age 80 years and older than among women ages 67-79 years, controlling for covariates. Black women tended to have radiotherapy omitted after breast conservation surgery 2.0 times more often (95% CI, 0.9-4.4) than white women (P = 0.09). Women age 80 years and older also were 70% less likely (odds ratio = 0.3; 95% CI, 0.1-0.8) to receive chemotherapy than women ages 67-79 years, controlling for health, functional status, and other covariates. CONCLUSIONS: After considering other factors, patient preferences and age were found to be associated with breast carcinoma treatment patterns in older women. Further research and training are needed to provide care for the growing population of older women that is both clinically appropriate and consonant with a woman's preferences.     

Patient and physician decision styles and breast cancer chemotherapy use in older women: Cancer and Leukemia Group B protocol 369901

PURPOSE Physician and patient decision styles may influence breast cancer care for patients ≥ 65 years ("older") because there is uncertainty about chemotherapy benefits in this group. We evaluate associations between decision-making styles and actual treatment. METHODS Data were collected from women treated outside of clinical trials for newly diagnosed stage I to III breast cancer (83% response) from January 2004 through April 2011 in 75 cooperative group sites. Physicians completed a one-time mailed survey (91% response), and clinical data were abstracted from charts. Patient decision style was measured on a five-point scale. Oncologists' preference for prescribing chemotherapy was based on standardized vignettes. Regression and multiple imputation were used to assess associations between chemotherapy and other variables. Results There were 1,174 women seen by 212 oncologists; 43% of women received chemotherapy. One-third of women preferred to make their own treatment decision. Patient and physician decision styles were independently associated with chemotherapy. Women who preferred less physician input had lower odds of chemotherapy than women who preferred more input (odds ratio [OR] = 0.79 per 1-point change; 95% CI, 0.65 to 0.97; P = .02) after considering covariates. Patients whose oncologists had a high chemotherapy preference had higher odds of receiving chemotherapy (OR = 2.65; 95% CI, 1.80 to 3.89; P < .001) than those who saw oncologists with a low preference. CONCLUSION Physicians' and older patients' decision styles are each associated with breast cancer chemotherapy use. It will be important to re-evaluate the impact of decision styles when there is greater empirical evidence about the benefits and risks of chemotherapy in older patients.     

The impact of colorectal cancer and self-efficacy beliefs on work ability and employment status: a longitudinal study

We examined how colorectal cancer patients' treatment and symptom management impacted perceptions of work ability and subsequent work decisions. Fifty patients completed questionnaires at baseline (post-surgery/pretreatment), 3 months and 6 months. Questionnaires assessed fatigue, depression, quality-of-life (QoL), cancer self-efficacy, job self-efficacy (JSE) and work ability. Factors related to perceived work ability were occupation (β= 0.31, P= 0.0005) and QoL (β= 0.42, P= 0.01) at baseline, treatment type (β=-0.19, P= 0.05) at 3 months, and JSE at 3 months (β= 0.57, P= 0.0005) and 6 months (β= 0.50, P= 0.006). Factors related to being on sick leave were lower levels of JSE (OR = 2.20, 95% CI: 1.17-4.13) at baseline and being employed in a manual occupation (OR = 0.03, 95% CI: 0.00-0.86), and perceived work ability (OR = 3.05, 95% CI: 1.00-12.80) at 6 months. Along with self-assessed work ability at baseline (β= 0.67, P= 0.0005), receiving chemotherapy or a combination of treatments (β=-0.24, P= 0.05) were the strongest predictors of poorer perceptions of follow-up work ability. Self-efficacy beliefs may add to understanding and should be considered in future research.     

Effects of aerobic exercise on cancer-related fatigue in breast cancer patients receiving chemotherapy: a meta-analysis

Increasing scientific evidences suggest that aerobic exercise may improve cancer-related fatigue in breast cancer patients, but many existing studies have yielded inconclusive results. This meta-analysis aimed to derive a more precise estimation of the effects of aerobic exercise on cancer-related fatigue in breast cancer patients receiving chemotherapy. The PubMed, CISCOM, CINAHL, Web of Science, Google Scholar, EBSCO, Cochrane Library, and CBM databases were searched from inception through July 1, 2013 without language restrictions. Crude standardized mean difference (SMD) with 95 % confidence interval (CI) was calculated. Twelve comparative studies were assessed with a total of 1,014 breast cancer patients receiving chemotherapy, including 522 patients in the aerobic exercise group (intervention group) and 492 patients in the usual care group (control group). The meta-analysis results revealed that the Revised Piper Fatigue Scale (RPFS) scores of breast cancer patients in the intervention group were significantly lower than those in the control group (SMD?=??0.82, 95% CI?=??1.04?～??0.60, P?<?0.001). However, there was no significant difference in the Functional Assessment of Chronic Illness Treatment-Fatigue scale (FACIT-F) scores between the intervention and control groups (SMD?=?0.09, 95% CI?=??0.07?～?0.25, P?=?0.224). Subgroup analysis by ethnicity indicated that there were significant differences in RPFS and FACIT-F scores between the intervention and control groups among Asian populations (RPFS: SMD?=??1.08, 95% CI?=??1.35?～??0.82, P?<?0.001; FACIT-F: SMD?=?1.20, 95 % CI?=?0.70?～?1.71, P?<?0.001), but not among Caucasian populations (all P?>?0.05). The current meta-analysis indicates that aerobic exercise may improve cancer-related fatigue in breast cancer patients receiving chemotherapy, especially among Asian populations.     

Dose-volumetric parameters of acute esophageal toxicity in patients with lung cancer treated with three-dimensional conformal radiotherapy

PURPOSE: To retrospectively evaluate which dose-volumetric parameters are associated with the risk of > or = Grade 3 acute esophageal toxicity (AET) in lung cancer patients treated with three-dimensional conformal radiotherapy (3D-CRT). METHODS AND MATERIALS: One hundred twenty-four lung cancer patients treated curatively with 3D-CRT were retrospectively analyzed. All patients received conventionally fractionated radiotherapy (RT) with median dose of 60 Gy (range, 54-66 Gy) delivered in 30 fractions (range, 27-33 fractions). Thirty-one patients underwent curative surgery before RT. Ninety-two patients received chemotherapy (induction, 18; concurrent +/- induction, 74). Acute esophageal toxicity was scored by Radiation Therapy Oncology Group criteria. The parameters analyzed included sex; age; Karnofsky performance score; weight loss; surgery; concurrent chemotherapy; the percentages of organ volume receiving > or =20 Gy (V20), > or =30 Gy (V30), > or =40 Gy (V40), > or =50 Gy (V50), > or =55 Gy (V55), > or = 58 Gy (V58), > or =60 Gy (V60), and > or =63 Gy (V63); the percent and absolute length of the esophagus irradiated; the maximum and mean dose to the esophagus; and normal tissue complication probability. RESULTS: Of the 124 patients, 15 patients (12.1%) had Grade 3 AET, and 1 (0.8%) patient had Grade 4 AET. There was no fatal Grade 5 AET. In univariate and multivariate logistic regression analyses, concurrent chemotherapy and V60 were significantly associated with the development of severe (> or = Grade 3) AET (p < 0.05). Severe AET was observed in 15 of 74 patients (20.3%) who received concurrent chemotherapy, and in 1 of 50 patients (2.0%) who did not (p = 0.002). Severe AET was observed in 5 of 87 patients (5.7%) with V60 < or = 30% and in 11 of 37 patients (29.7%) with V60 > 30% (p < 0.001). Among 50 patients who did not receive concurrent chemotherapy, severe AET was observed in 0 of 43 patients (0%) with V60 < or = 30% and in 1 of 7 patients (14.2%) with V60 > 30% (p = 0.140). Among 74 patients who received concurrent chemotherapy, severe AET was observed in 5 of 44 patients (11.4%) with V60 < or = 30% and in 10 of 30 patients (33.3%) with V60 > 30% (p = 0.037). CONCLUSIONS: Concurrent chemotherapy and V60 were associated with the development of severe AET > or = Grade 3. For patients being treated with concurrent chemotherapy, V60 is considered to be a useful parameter predicting the risk of severe AET after conventionally fractionated 3D-CRT for lung cancer.     

Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes.

PURPOSE: To determine the effects of exercise training on cardiopulmonary function and quality of life (QOL) in postmenopausal breast cancer survivors who had completed surgery, radiotherapy, and/or chemotherapy with or without current hormone therapy use. METHODS: Fifty-three postmenopausal breast cancer survivors were randomly assigned to an exercise (n = 25) or control (n = 28) group. The exercise group trained on cycle ergometers three times per week for 15 weeks at a power output that elicited the ventilatory equivalent for carbon dioxide. The control group did not train. The primary outcomes were changes in peak oxygen consumption and overall QOL from baseline to postintervention. Peak oxygen consumption was assessed by a graded exercise test using gas exchange analysis. Overall QOL was assessed by the Functional Assessment of Cancer Therapy-Breast scale. RESULTS: Fifty-two participants completed the trial. The exercise group completed 98.4% of the exercise sessions. Baseline values for peak oxygen consumption (P =.254) and overall QOL (P =.286) did not differ between groups. Peak oxygen consumption increased by 0.24 L/min in the exercise group, whereas it decreased by 0.05 L/min in the control group (mean difference, 0.29 L/min; 95% confidence interval [CI], 0.18 to 0.40; P <.001). Overall QOL increased by 9.1 points in the exercise group compared with 0.3 points in the control group (mean difference, 8.8 points; 95% CI, 3.6 to 14.0; P =.001). Pearson correlations indicated that change in peak oxygen consumption correlated with change in overall QOL (r = 0.45; P <.01). CONCLUSION: Exercise training had beneficial effects on cardiopulmonary function and QOL in postmenopausal breast cancer survivors.     

Quality of life is predictive of survival in patients with unresectable hepatocellular carcinoma.

BACKGROUND: Patients with unresectable hepatocellular carcinoma (HCC) have a dismal prognosis. The objective of this study was to evaluate whether patient-reported baseline quality of life (QoL) measured by the EORTC QLQ-C30 instrument is predictive of survival for these patients. MATERIALS AND METHODS: Two hundred and thirty-three patients with unresectable HCC (mainly hepatitis B-associated) who were recruited into two separate randomized phase III clinical studies, based on palliative chemotherapy and palliative hormonal therapy, respectively, gave consent and received pretreatment QoL assessment. EORTC QLQ-C30 scores and clinical variables at the time of study entry were analyzed to identify factors that influenced survival by applying multivariate analysis. Independent prognostic factors for survival were studied by Cox regression analysis. RESULTS: Median survival of the 233 patients was 5.5 months (95% CI 4.2-6.5 months). Significant independent predictors of shorter survival were advanced Okuda staging (P = 0.0030; HR = 2.058), high baseline total bilirubin (P = 0.0008; HR = 1.013) and worse QoL score in the appetite score domain (P = 0.0028; HR for 10 point increase = 1.070). Patients who were entered into the chemotherapy trial (P = 0.0002; HR = 0.503), those who scored better in the physical functioning domain (P = 0.0034; HR for 10 point decrease = 0.911) and the role functioning domain (P = 0.0383; HR for 10 point decrease = 0.944) of the QoL questionnaire, were associated with longer survival. CONCLUSIONS: In the studied HCC population, patient-reported baseline QoL provides additional prognostic information that supplements traditional clinical factors, and is a new prognostic marker for survival for patients with unresectable HCC.     

Second-line chemotherapy for patients with advanced gastric cancer: who may benefit?

No established second-line chemotherapy is available for patients with advanced gastric cancer failing to respond or progressing to first-line chemotherapy. However, 20-40% of these patients commonly receive second-line chemotherapy. We evaluated the influence of clinico-pathologic factors on the survival of 175 advanced gastric cancer patients, who received second-line chemotherapy at three oncology departments. Univariate and multivariate analyses found five factors which were independently associated with poor overall survival: performance status 2 (hazard ratio (HR), 1.79; 95% CI, 1.16-2.77; P=0.008), haemoglobin 50 ng ml(-1) (HR, 1.86; 95% CI, 1.21-2.88; P=0.004), the presence of greater than or equal to three metastatic sites of disease (HR, 1.72; 95% CI, 1.16-2.53; P=0.006), and time-to-progression under first-line chemotherapy 相似文献   

Nutrition intervention is beneficial in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area

Malnutrition occurs frequently in patients with cancer of the gastrointestinal (GI) or head and neck area and can lead to negative outcomes. The aim of this study is to determine the impact of early and intensive nutrition intervention (NI) on body weight, body composition, nutritional status, global quality of life (QoL) and physical function compared to usual practice in oncology outpatients receiving radiotherapy to the GI or head and neck area. Outpatients commencing at least 20 fractions of radiotherapy to the GI or head and neck area were randomised to receive intensive, individualised nutrition counselling by a dietitian using a standard protocol and oral supplements if required, or the usual practice of the centre (general advice and nutrition booklet). Outcome parameters were measured at baseline and 4, 8 and 12 weeks after commencing radiotherapy using valid and reliable tools. A total of 60 patients (51 M : 9 F; mean age 61.9+/-14.0 years) were randomised to receive either NI (n=29) or usual care (UC) (n=31). The NI group had statistically smaller deteriorations in weight (P<0.001), nutritional status (P=0.020) and global QoL (P=0.009) compared with those receiving UC. Clinically, but not statistically significant differences in fat-free mass were observed between the groups (P=0.195). Early and intensive NI appears beneficial in terms of minimising weight loss, deterioration in nutritional status, global QoL and physical function in oncology outpatients receiving radiotherapy to the GI or head and neck area. Weight maintenance in this population leads to beneficial outcomes and suggests that this, rather than weight gain, may be a more appropriate aim of NI.     

晚期十二指肠癌化疗的方案和疗效比较

  目的  通过回顾性分析晚期原发十二指肠癌的化疗疗效,探索十二指肠癌的有效化疗方案。  方法  选取2002年1月至2012年12月北京朝阳区三环肿瘤医院收治的晚期原发十二指肠癌患者56例,分析化疗的有效率、疾病控制率,对无进展生存及总生存率的影响。  结果  化疗总有效率19.04%,疾病控制率71.42%,其中氟尿嘧啶联合奥沙利铂方案（FOLFOX）有效率高于其他方案（35.29% vs. 7.69%,P=0.011）;同未化疗患者相比,化疗延长晚期原发十二指肠癌患者的生存时间（13.35个月vs. 5.65个月,HR=0.20,95%CI:0.083~0.497,P=0.000 5）;以氟尿嘧啶类为基础的化疗方案优于其他化疗方案,可延长无进展生存（5.08个月vs. 1.08个月,HR=0.004,95%CI:0.000~0.315,P=0.013 2）。多因素分析表明,淋巴结转移及病理检测存在黏液腺癌组织是十二指肠癌的独立预后因素。  结论  姑息性化疗可能提高晚期十二指肠癌患者的总生存率。      

Effect of cognitive-existential group therapy on survival in early-stage breast cancer.

PURPOSE: Cognitive-existential group therapy (CEGT) was developed to improve mood and mental attitude toward cancer in women with early-stage breast cancer receiving adjuvant chemotherapy. Given the debate about group therapy's association with increased survival in women with metastatic breast cancer, we were curious to check its effect at a much earlier stage in the cancer journey. PATIENTS AND METHODS: We randomly assigned 303 women with early-stage breast cancer who were receiving adjuvant chemotherapy to either 20 sessions of weekly group therapy plus three relaxation classes (n = 154) or to a control condition of three relaxation classes alone (n = 149). The primary outcome was survival. RESULTS: CEGT did not extend survival; the median survival time was 81.9 months (95% CI, 64.8 to 99.0 months) in the group-therapy women and 85.5 months (95% CI, 67.5 to 103.6 months) in the control arm. The hazard ratio for death was 1.35 (95% CI, 0.76 to 2.39; P = .31). In contrast, histology and axillary lymph node status were significant predictors of survival. Low-grade histology yielded a hazard ratio of 0.342 (95% CI, 0.17 to 0.69), and axillary lymph node-negative status yielded a hazard ratio of 0.397 (95% CI, 0.20 to 0.78). CONCLUSION: CEGT does not prolong survival in women with early-stage breast cancer.     

Double-blind,placebo-controlled,randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy

BACKGROUND: Patients receiving chemotherapy often develop anemia. Darbepoetin alfa (Aranesp(TM)) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy. METHODS: In this multicenter, double-blind, placebo-controlled study, 320 anemic patients (hemoglobin or=25% improvement; mean difference = 13%; 95% CI = 2% to 23%, P =.019) than patients receiving placebo. Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug. Adverse events were similar between the groups. CONCLUSIONS: Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy. Darbepoetin alfa decreased blood transfusion requirements, increased hemoglobin concentration, and decreased fatigue. Although no conclusions can be drawn about survival from this study, the potential salutary effect on disease outcome warrants further investigation in a prospectively designed study.     

A meta-analysis of two randomised trials of early chemotherapy in asymptomatic metastatic colorectal cancer

This report constitutes a prospectively planned meta-analysis combining two almost identical trials undertaken in Australasia and Canada to study the effect of starting chemotherapy immediately in asymptomatic patients with metastatic colorectal cancer. Patients (n=168) were randomised to receive either immediate or delayed treatment (at onset of predefined symptoms). Australasian patients received either weekly 5-fluorouracil and leucovorin (500 and 20 mg m(-2), respectively) (n=59) or the daily x 5 Mayo Clinic schedule (425 and 20 mg m(-2), respectively) (n=42). Canadian patients were treated with the Mayo schedule (n=67). Otherwise, the two studies were almost identical in design and each used the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 instrument for measuring quality of life (QoL). Treatment was continued until 6 months had elapsed or disease progression occurred. Low accrual led to trial suspension before the predetermined sample size for either study was reached. Median survival was not significantly better with immediate treatment (median 13.0 vs 11.0 months; hazard ratio, 1.15; 95% confidence interval (CI) 0.79-1.72; P=0.49). There was no statistically significant difference in progression-free survival (time from randomisation until first evidence of progression after chemotherapy, 10.2 vs 10.8 months; hazard ratio, 1.08; 95% CI 0.71-1.64; P=0.73). There was no difference in overall QoL or its individual domains between the two treatment strategies at baseline or at any subsequent time point. Early treatment of asymptomatic patients with metastatic colorectal cancer did not provide a survival benefit or improved QoL compared to withholding treatment until symptoms occurred.     

Identification of paediatric cancer patients with poor quality of life

The primary objective was to describe predictors of physical, emotional and social quality of life (QoL) in children receiving active treatment for cancer. This Canadian multi-institutional cross-sectional study included children with cancer receiving any type of active treatment. The primary caregiver provided information on child physical, emotional and social QoL according to the PedsQL 4.0 Generic Core scales. Between November 2004 and February 2007, 376 families provided the data. In multiple regression, children with acute lymphoblastic leukemia had better physical health (OR: 0.37, 95% CI 0.23, 0.60; P<0.0001) while intensive chemotherapy treatment (OR: 2.34, 95% CI: 1.42, 3.85; P=0.0008) and having a sibling with a chronic condition (OR: 2.53, 95% CI: 1.54, 4.15; P=0.0002) were associated with poor physical QoL. Better emotional health was associated with good prognosis, less intensive chemotherapy treatment and greater household savings, whereas female children and those with a sibling with a chronic condition had poor social QoL. Physical, emotional and social QoL are influenced by demographic, diagnostic and treatment variables. Sibling and household characteristics are associated with QoL. This information will help to identify children at higher risk of poor QoL during treatment for cancer.     

The effect of a whole body exercise programme and dragon boat training on arm volume and arm circumference in women treated for breast cancer

The purpose of this study was to examine the effect of a whole body exercise programme and dragon boat training on changes in arm volume in breast cancer survivors. A total of 16 female breast cancer survivors with no clinical history of lymphoedema volunteered. The 20-week exercise programme consisted of resistance and aerobic exercise with the addition of dragon boat training at week 8. Arm circumference at two sites (CIRC10, CIRC15), arm volume (VOL), and upper body strength (1-RM) were measured at baseline (T1), week 8 (T2), and week 20 (T3). All statistical tests were two-sided (alpha < or = 0.05). No significant differences between the ipsilateral and contralateral upper extremities at any of the three time points were found. All variables significantly increased from T1 to T3 (CIRC10: difference, d = 0.49 cm, 95% confidence interval, CI = 0.25-0.73, P = 0.000; CIRC15: d = 1.33 cm, CI = 0.78-1.88, P = 0.000; VOL: d = 100 mL, CI = 69-130, P = 0.000). As well, 1-RM significantly increased from T1 to T3 (d = 10.8 kg, CI = 5.6-16.1; P = 0.000). In summary, participation in a whole body exercise programme and dragon boat training resulted in a significant increase in upper extremity volume over time. However, the changes were consistent for both arms and the significant gain in upper body muscular strength likely accounted for the increase in arm volume.